MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; BED, PEDIATRIC OPEN HOSPITAL

Model Number FL19H

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.9 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 11 malfunction events, where it was reported the devices experienced a siderail false latch or the access door opens unexpectedly.There was no patient involvement.

Event Description

This report summarizes 11 malfunction events, where it was reported the devices experienced a siderail false latch or the access door opens unexpectedly.There was no patient involvement.

Manufacturer Narrative

The final device was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.

• Brand Name: CUB PEDIATRIC CRIB- HYD BASE
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12696875
• MDR Text Key: 278357674
• Report Number: 0001831750-2021-01539
• Device Sequence Number: 1
• Product Code: FMS
• UDI-Device Identifier: 07613327169348
• UDI-Public: 07613327169348
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 11
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FL19H
• Device Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1